– Preclinical models have demonstrated the ability to resist oncolytic virus inactivation by human serum and target diverse tumor types

– Novel therapeutic approach allows for ease of administration, increased cost-effectiveness, and the ability to reach a broad patient population

– Systemic enveloped solution builds upon Calidi’s years of experience in effectively using cells to protect oncolytic viruses from being neutralized by the patient’s immune system

Calidi Biotherapeutics, Inc. (NYSEAM: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced an upcoming presentation to provide details on the development of the Company’s systemic enveloped oncolytic virotherapy platform which has the potential to provide a universal treatment for a broad range of advanced tumor types. Stephen Thesing, Chief Business Officer of Calidi, will be presenting at the Biocom Global Life Science Partnering & Investor Conference on February 28, 2024 at 3:00 p.m. PT, to discuss the Company’s newly announced systemic enveloped oncolytic virotherapy program targeting all tumor types, including advanced metastatic disease, and provide an update on the clinical development progress of Calidi’s CLD-101 (NeuroNova) and CLD-201 (SuperNova) programs.

Calidi's systemic enveloped virotherapy program, ImmunoNova, leverages extensive experience in utilizing cells to protect, potentiate and deliver virotherapies. Utilizing an engineered and enveloped vaccinia virus, ImmunoNova shows promising potential in targeting advanced metastatic disease across the body, while maintaining survival in the bloodstream. Preclinical models have demonstrated ImmunoNova's efficacy in transforming tumor immune microenvironments and eradicating distant and diverse tumors. In addition, the program exhibits synergistic potential with other immunotherapies, including cell therapies, enhancing its ability to attack and eliminate disseminated solid tumors.

“Calidi's groundbreaking systemic enveloped virotherapy holds immense promise in revolutionizing the treatment landscape for cancer patients with advanced solid tumors. By priming the tumor microenvironment, our therapy empowers immune cells, activates the immune system, and ultimately eliminates tumors,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We are encouraged by the promising preclinical data from our new program and while continuing to advance our existing clinical pipeline to fight cancer on all fronts.”

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” ��may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Registration Statements filed with the SEC on Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023, on Form 10-Q filed on November 14, 2023, and on Form S-1 filed on January 29, 2024, as amended on February 7, 2024.

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